| Results of the first randomized French study evaluating self-testing of the International Normalized Ratio. | |
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MedLine Citation:
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PMID: 22066355 Owner: NLM Status: In-Process |
Abstract/OtherAbstract:
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BACKGROUND AND AIM OF THE STUDY: In this single-center French study, the conventional management of patients receiving vitamin K antagonists (VKAs) was compared with an International Normalized Ratio (INR) self-testing program. The aim was to determine the reliability of self-testing devices, and to estimate the variability of the self-measured INR within the therapeutic and target range. METHODS: A total of 206 patients who had undergone valve replacement with a mechanical prosthesis, with or without myocardial revascularization, between May 2004 and September 2007 was randomized into two groups. Group 1 patients (n = 103) underwent INR monitoring at a laboratory, while Group 2 patients (n = 103) underwent self-testing INR using either the CoaguChek (Roche) (Group 2A; n = 55) or INRatio (Hemosense) (Group 2B; n = 48) system. Patients in Group 1 underwent at least once-monthly INR measurement, while those in Group 2 carried out once-weekly self-testing, and also underwent once-monthly INR measurement at the laboratory. The large majority of patients (97.9%) were treated with fluindione. RESULTS: The mean follow up period was 49.0 +/- 10.3 weeks. Self-testing was reliable, with a correlation coefficient between device- and laboratory-measured INRs of 0.80 [CI: 0.78, 0.82] (p < 0.0001). The proportion of time spent within the INR target range was significantly higher for Group 2 (61.5 +/- 19.3% versus 55.5 +/- 19.9%; p < 0.05), while the absolute mean deviation of INR from the target range was higher in Group 1 (60.1 +/- 70.2% versus 47.4 +/- 51.5%). Adverse events were reported by seven patients in Group 1, but by no patients in Group 2 (p < 0.01). CONCLUSION: INR self-testing devices are reliable and beneficial. Moreover, INR self-monitoring allows an enhanced stability within a target range, and also helps to prevent serious postoperative complications. |
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Authors:
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Kasra Azarnoush; Lionel Camilleri; Bruno Aublet-Cuvelier; Etienne Geoffroy; Claire Dauphin; Claude Dubray; Charles De Riberolles |
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Publication Detail:
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Type: Journal Article; Research Support, Non-U.S. Gov't |
Journal Detail:
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Title: The Journal of heart valve disease Volume: 20 ISSN: 0966-8519 ISO Abbreviation: J. Heart Valve Dis. Publication Date: 2011 Sep |
Date Detail:
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Created Date: 2011-11-09 Completed Date: - Revised Date: - |
Medline Journal Info:
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Nlm Unique ID: 9312096 Medline TA: J Heart Valve Dis Country: England |
Other Details:
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Languages: eng Pagination: 518-25 Citation Subset: IM |
Affiliation:
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Heart Surgery Department, Hôpital Gabriel Montpied CHU Clermont-Ferrand, France. kazarnoush@chu-Clermontferrand.fr |
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From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine
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